IMPAACT2002: Behavioral Therapy and Medication for Depression among Youth with HIV

Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression among Youth Living with HIV in the U.S.

Categories:

Psychology

Infectious Diseases

Diseases Treated:

Depression

Eligibility Overview:

  • 12 to 24 years old
  • Receiving mental health or HIV-related care at participating IMPAACT site
  • HIV-positive
  • Diagnosis of nonpsychotic depression
  • Current depressive symptoms that warrant intervention
  • Reads and speaks English
  1. Brief Summary

    Some reports have indicated as many as half of HIV-positive youth may suffer from depression. Previous studies have shown depression leads to reduced adherence to HIV treatment and poorer medical outcomes as well as poorer functional outcomes.

    A number of clinical trials have shown the use of medication algorithms and cognitive behavioral therapy is most effective for the treatment of moderate and severe depression in adult, non-HIV infected patients. However, little research has been conducted on the treatment of depression among HIV-infected adolescents and young adults. Younger patients, for example, respond differently to antidepressant treatments and have lower adherence to mental health therapies. More study is needed to tailor depression treatment to this specific population.

    Primary Objectives

    • To evaluate whether the Health and Wellness Cognitive Behavioral Therapy and Medical Management Algorithm (COMB-R) treatment for depression is associated with improved depression outcomes at 24 weeks, compared to Enhanced Standard Care (ESC)
    • To evaluate whether COMB-R is associated with improved biological measures of health over 24 weeks, compared to ESC

    Eligibility Criteria

    Inclusion criteria include:

    • 12 to 24 years old
    • Receiving mental health or HIV-related care at participating IMPAACT site
    • HIV-positive
    • Aware of own HIV infection
    • Diagnosis of nonpsychotic depression
    • Current depressive symptoms that warrant intervention
    • Reads and speaks English

    Exclusion Criteria include:

    • Psychotic disorder and/or bipolar disorder
    • Condition requires more intensive treatment

    Study Sites

    St. Jude Children’s Research Hospital and other collaborating sites in the U.S.
    Memphis, Tennessee

  2. About this study

    HIV is the term used for human immunodeficiency virus. It is a virus that attacks the body’s immune system and weakens your ability to fight off infection. HIV is spread from one person to another person through contact with blood and some other bodily fluids.

    Many adolescents and young adults with HIV struggle with depression. Left untreated, depression can lead to more serious health problems. It can also make it harder to perform everyday tasks and functions.

    This study is open to adolescents and young adults with HIV and depression. St. Jude is one of several locations in the United States where the study will be held.

    If you participate in this study at St. Jude, you will receive counseling, also known as Cognitive Behavioral Therapy. You may also be given medicine. Researchers will use a special method, known as an algorithm, to review and suggest medicines to treat your depression. Results of this study may improve your overall health and help you learn how to manage symptoms of depression in the future.

    Purpose of this clinical trial

    The main purpose of this trial is to see how well the combination of a specific type of counseling and medication management treats depression in adolescents and young adults with HIV. Researchers want to find out if this combination therapy treats depression better than standard treatment.

    Eligibility overview

    • 12 to 24 years old
    • Receiving mental health or HIV-related care at participating IMPAACT site
    • HIV-positive
    • Diagnosis of nonpsychotic depression
    • Current depressive symptoms that warrant intervention
    • Reads and speaks English
  3. IMPAACT2002  Quick View
    Sponsor International Maternal Pediatric Adolescent AIDS Clinical Trials Group
    Clinicaltrials.gov identifier NCT02939131   
    Trial start date November 2016
    Estimated enrollment 156 nationwide
    Study type Interventional
    Conditions Depression, HIV
    Ages 12 to 24 years old
    Principal investigator Megan Wilkins, PhD
    Study site St. Jude Children’s Research Hospital and other collaborating sites in the U.S.
    For a consultation or to discuss IMPAACT2002
    St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org
     

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.